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Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

Primary Purpose

Pain, Postoperative, Otitis Media

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac
Fentanyl
Sponsored by
Anica Crnkovic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

8 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist (ASA) I-II physical class
  • Scheduled for elective BMT
  • Mask induction of anesthesia

Exclusion Criteria:

  • Allergy to any NSAIDs
  • Severe upper respirator infection
  • Severe asthma
  • Bleeding disorders
  • History of GI bleeding
  • Renal impairment
  • Scheduled for one-sided myringotomy and tube placement

Sites / Locations

  • Albany Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ketorolac

Fentanyl

Ketorolac and Fentanyl

Arm Description

Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.

Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.

Outcomes

Primary Outcome Measures

Pain score assessment
Pain assessment score using CHEOPS

Secondary Outcome Measures

Administration of additional pain medication
The need for additional pain medication other than the study medication to control postoperative pain

Full Information

First Posted
January 8, 2016
Last Updated
September 9, 2021
Sponsor
Anica Crnkovic
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1. Study Identification

Unique Protocol Identification Number
NCT02653742
Brief Title
Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children
Official Title
Prospective, Randomized, Allocation-Concealed, Blinded Study Designed to Compare Ketorolac Sublingual and Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anica Crnkovic

4. Oversight

Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of ketorolac sublingual with fentanyl intranasal used in our hospital for pain control in children undergoing bilateral myringotomy with placement of pressure equalization tubes (BMTs).
Detailed Description
This prospective, randomized, allocation concealed blinded study is designed to compare ketorolac sublingual vs. fentanyl intranasal vs. the combination of these two medications for pain control after BMTs in children. Bilateral myringotomy and tube placement is an elective operation, mainly in the pediatric population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use.
Arm Title
Fentanyl
Arm Type
Experimental
Arm Description
Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.
Arm Title
Ketorolac and Fentanyl
Arm Type
Experimental
Arm Description
Ketorolac 1mg/kg sublingual, in the form of Ketorolac Tromethamine solution for intravenous/intramuscular use and Fentanyl 2mcg/kg intranasal, in the form of Fentanyl Citrate solution for intravenous/intramuscular use.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia
Primary Outcome Measure Information:
Title
Pain score assessment
Description
Pain assessment score using CHEOPS
Time Frame
Through study completion, an average of 1 hour postop
Secondary Outcome Measure Information:
Title
Administration of additional pain medication
Description
The need for additional pain medication other than the study medication to control postoperative pain
Time Frame
Through study completion, an average of 1 hour postop

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist (ASA) I-II physical class Scheduled for elective BMT Mask induction of anesthesia Exclusion Criteria: Allergy to any NSAIDs Severe upper respirator infection Severe asthma Bleeding disorders History of GI bleeding Renal impairment Scheduled for one-sided myringotomy and tube placement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Farzana Afroze, MD
Phone
518-262-4300
Email
afrozef@mail.amc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Anica Crnkovic, MD
Phone
518-262-4300
Email
CrnkovA@mail.amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anica Crnkovic, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
2330920
Citation
Croteau N, Hai V, Pless IB, Infante-Rivard C. Trends in medical visits and surgery for otitis media among children. Am J Dis Child. 1990 May;144(5):535-8. doi: 10.1001/archpedi.1990.02150290029019.
Results Reference
background
PubMed Identifier
1394752
Citation
Watcha MF, Ramirez-Ruiz M, White PF, Jones MB, Lagueruela RG, Terkonda RP. Perioperative effects of oral ketorolac and acetaminophen in children undergoing bilateral myringotomy. Can J Anaesth. 1992 Sep;39(7):649-54. doi: 10.1007/BF03008224.
Results Reference
background
PubMed Identifier
5534693
Citation
Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.
Results Reference
background
PubMed Identifier
19020154
Citation
Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008 Dec;107(6):2025-31. doi: 10.1213/ane.0b013e318188b736. Erratum In: Anesth Analg. 2009 Mar;108(3):991. Dosage error in published abstract; MEDLINE/PubMed abstract corrected; Dosage error in article text.
Results Reference
background
PubMed Identifier
15675931
Citation
Gupta A, Daggett C, Ludwick J, Wells W, Lewis A. Ketorolac after congenital heart surgery: does it increase the risk of significant bleeding complications? Paediatr Anaesth. 2005 Feb;15(2):139-42. doi: 10.1111/j.1460-9592.2005.01409.x.
Results Reference
background
PubMed Identifier
21683202
Citation
Aldrink JH, Ma M, Wang W, Caniano DA, Wispe J, Puthoff T. Safety of ketorolac in surgical neonates and infants 0 to 3 months old. J Pediatr Surg. 2011 Jun;46(6):1081-5. doi: 10.1016/j.jpedsurg.2011.03.031.
Results Reference
background
PubMed Identifier
15153212
Citation
Papacci P, De Francisci G, Iacobucci T, Giannantonio C, De Carolis MP, Zecca E, Romagnoli C. Use of intravenous ketorolac in the neonate and premature babies. Paediatr Anaesth. 2004 Jun;14(6):487-92. doi: 10.1111/j.1460-9592.2004.01250.x.
Results Reference
background
PubMed Identifier
21199130
Citation
Lynn AM, Bradford H, Kantor ED, Andrew M, Vicini P, Anderson GD. Ketorolac tromethamine: stereo-specific pharmacokinetics and single-dose use in postoperative infants aged 2-6 months. Paediatr Anaesth. 2011 Mar;21(3):325-34. doi: 10.1111/j.1460-9592.2010.03484.x. Epub 2010 Dec 29.
Results Reference
background
PubMed Identifier
21233498
Citation
Cohen MN, Christians U, Henthorn T, Vu Tran Z, Moll V, Zuk J, Galinkin J. Pharmacokinetics of single-dose intravenous ketorolac in infants aged 2-11 months. Anesth Analg. 2011 Mar;112(3):655-60. doi: 10.1213/ANE.0b013e3182075d04. Epub 2011 Jan 13.
Results Reference
background
PubMed Identifier
12760984
Citation
Pappas AL, Fluder EM, Creech S, Hotaling A, Park A. Postoperative analgesia in children undergoing myringotomy and placement equalization tubes in ambulatory surgery. Anesth Analg. 2003 Jun;96(6):1621-1624. doi: 10.1213/01.ANE.0000064206.51296.1D.
Results Reference
background
PubMed Identifier
19300040
Citation
Zuppa AF, Mondick JT, Davis L, Cohen D. Population pharmacokinetics of ketorolac in neonates and young infants. Am J Ther. 2009 Mar-Apr;16(2):143-6. doi: 10.1097/MJT.0b013e31818071df.
Results Reference
background
PubMed Identifier
23702435
Citation
Neri E, Maestro A, Minen F, Montico M, Ronfani L, Zanon D, Favret A, Messi G, Barbi E. Sublingual ketorolac versus sublingual tramadol for moderate to severe post-traumatic bone pain in children: a double-blind, randomised, controlled trial. Arch Dis Child. 2013 Sep;98(9):721-4. doi: 10.1136/archdischild-2012-303527. Epub 2013 May 23.
Results Reference
background
PubMed Identifier
15365927
Citation
Gupta A, Daggett C, Drant S, Rivero N, Lewis A. Prospective randomized trial of ketorolac after congenital heart surgery. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):454-7. doi: 10.1053/j.jvca.2004.05.024.
Results Reference
background
PubMed Identifier
12434509
Citation
Perez-Urizar J, Aguilar-Cota ME, Herrera JE, Flores-Murrieta FJ. Comparative bioavailability of ketorolac tromethamine after intramuscular and sublingual administration. Proc West Pharmacol Soc. 2002;45:6-7. No abstract available.
Results Reference
background
PubMed Identifier
22467894
Citation
Drover DR, Hammer GB, Anderson BJ. The pharmacokinetics of ketorolac after single postoperative intranasal administration in adolescent patients. Anesth Analg. 2012 Jun;114(6):1270-6. doi: 10.1213/ANE.0b013e31824f92c2. Epub 2012 Mar 30.
Results Reference
background
PubMed Identifier
23098098
Citation
He A, Hersh EV. A review of intranasal ketorolac tromethamine for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. Curr Med Res Opin. 2012 Dec;28(12):1873-80. doi: 10.1185/03007995.2012.744302. Epub 2012 Nov 9.
Results Reference
background
PubMed Identifier
22574632
Citation
Garnock-Jones KP. Intranasal ketorolac: for short-term pain management. Clin Drug Investig. 2012 Jun 1;32(6):361-71. doi: 10.2165/11209240-000000000-00000.
Results Reference
background
PubMed Identifier
11323340
Citation
Finkel JC, Cohen IT, Hannallah RS, Patel KM, Kim MS, Hummer KA, Choi SS, Pena M, Schreiber SB, Zalzal G. The effect of intranasal fentanyl on the emergence characteristics after sevoflurane anesthesia in children undergoing surgery for bilateral myringotomy tube placement. Anesth Analg. 2001 May;92(5):1164-8. doi: 10.1097/00000539-200105000-00016.
Results Reference
background
PubMed Identifier
11149429
Citation
Galinkin JL, Fazi LM, Cuy RM, Chiavacci RM, Kurth CD, Shah UK, Jacobs IN, Watcha MF. Use of intranasal fentanyl in children undergoing myringotomy and tube placement during halothane and sevoflurane anesthesia. Anesthesiology. 2000 Dec;93(6):1378-83. doi: 10.1097/00000542-200012000-00006.
Results Reference
background
PubMed Identifier
8489062
Citation
Karl HW, Rosenberger JL, Larach MG, Ruffle JM. Transmucosal administration of midazolam for premedication of pediatric patients. Comparison of the nasal and sublingual routes. Anesthesiology. 1993 May;78(5):885-91. doi: 10.1097/00000542-199305000-00013.
Results Reference
background
PubMed Identifier
9188114
Citation
Bean-Lijewski JD, Stinson JC. Acetaminophen or ketorolac for post myringotomy pain in children? A prospective, double-blinded comparison. Paediatr Anaesth. 1997;7(2):131-7. doi: 10.1046/j.1460-9592.1997.d01-47.x.
Results Reference
background
PubMed Identifier
9187531
Citation
Forrest JB, Heitlinger EL, Revell S. Ketorolac for postoperative pain management in children. Drug Saf. 1997 May;16(5):309-29. doi: 10.2165/00002018-199716050-00003.
Results Reference
background
PubMed Identifier
9895062
Citation
Davis PJ, Greenberg JA, Gendelman M, Fertal K. Recovery characteristics of sevoflurane and halothane in preschool-aged children undergoing bilateral myringotomy and pressure equalization tube insertion. Anesth Analg. 1999 Jan;88(1):34-8. doi: 10.1097/00000539-199901000-00007.
Results Reference
background
PubMed Identifier
17456651
Citation
Lynn AM, Bradford H, Kantor ED, Seng KY, Salinger DH, Chen J, Ellenbogen RG, Vicini P, Anderson GD. Postoperative ketorolac tromethamine use in infants aged 6-18 months: the effect on morphine usage, safety assessment, and stereo-specific pharmacokinetics. Anesth Analg. 2007 May;104(5):1040-51, tables of contents. doi: 10.1213/01.ane.0000260320.60867.6c.
Results Reference
background

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Ketorolac Sublingual vs. Fentanyl Intranasal in Pain Control for Bilateral Myringotomy and Tubes (BMT) Placement in Children

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